MAUDE Adverse Event Report: TERUMO CARDIOVASCULAR SYSTEMS CORP. CAPIOX RX25 OXYGENATOR EAST; BLOOD GAS OXYGENATOR

Model Number 3CX*RX25RE

Device Problem Use of Device Problem (1670)

Patient Problem No Patient Involvement (2645)

Event Type  malfunction  

Manufacturer Narrative

Terumo has not received the actual device for evaluation; therefore, the investigation has yet to be completed.Terumo plans on submitting a follow-up report when the investigation is complete and more information becomes available.(b)(4).

Event Description

Terumo cardiovascular was made aware of a perfusion article (vol.31) that addressed where the vavd vacuum may cause bubble transgression in membrane oxygenators.This was printed by sage journals.Authors include k.Nygaard, as.Thiara, c.Tronstad, ma.Ringdal, and ae.Fiane.There was no patient involvement as this was a study and not during a procedure.

Manufacturer Narrative

There were no samples returned for evaluation.Review of the test method indicated in the literature found the points below to differ from the actual use of the device.-in the circuit described in the literature, there is a possibility that the negative pressure inside the reservoir may be transferred into the oxygenator module via the purge line (de-air line).During the circulation in the actual use of the oxygenator, however, the purge line must be clamped.There is, therefore, no way for the negative pressure to be transferred into the oxygenator module via the purge line.-in the circuit described in the literature, there is a possibility that the negative pressure inside the reservoir may be transferred into the oxygenator module via the arterial line of the oxygenator module.During the circulation in the actual use of the oxygenator, however, the arterial line is connected to the patient.There is, therefore, no way for the negative pressure to be transferred into the oxygenator module via the arterial line.-the literature describes the hypothesis that vavd vacuum may cause a sub atmospheric pressure in the blood component of an oxygenator when the arterial pump is stopped and this pressure difference may cause bubble transgression form the sweep gas into the blood.The ifu of this product does prohibit this action.All available information has been placed on file in quality management for appropriate tracking, trending, and follow-up.

• Brand Name: CAPIOX RX25 OXYGENATOR EAST
• Type of Device: BLOOD GAS OXYGENATOR
• Manufacturer (Section D): TERUMO CARDIOVASCULAR SYSTEMS CORP.; 125 blue ball road; elkton MD 21921
• Manufacturer Contact: cathleen hargreaves ; 125 blue ball road; elkton, MD 21921 ; 8002837866
• MDR Report Key: 6312574
• MDR Text Key: 66874260
• Report Number: 1124841-2017-00015
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K153213
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/08/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 3CX*RX25RE
• Device Catalogue Number: N/A
• Device Lot Number: UNKNOWN
• Other Device ID Number: (01)00699753450103
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 03/07/2017
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1